Device product
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Z-2617-2021
Product summary
- Event
- Event 88596
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 boxes (5/each)= 20 eaches
- Official record key
device-enforcement:Z-2617-2021
Official wording
Reason: Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Code information: Lot Number: 5210162 (UDI): H96560M7019951
Distribution pattern: Canada
Derived failure modes
-
Labeling or packaging
Mislabeled